The FDA recently issued a Class I recall on a heart device. A Class I recall means that the device may cause serious injury or death. The device that was recalled is the HeartMate 3 Left Ventricular Assist System.
The manufacturer of the device, Abbott, issued a recall because of a malfunction in the device’s outflow graft assembly. The malfunction may cause the device to twist and close up over time. This can reduce or even stop the pump’s flow and trigger a persistent low flow alarm in the system. According to the FDA, blood clots or even death can occur from a reduction in pump flow.
The company is recalling almost 5,000 units that were distributed between 2014 and today. Patients who experience a persistent low flow alarm are urged to contact their doctors. The company is not recommending that the device be removed. Any physicians whose patients are experiencing adverse events are encouraged to report those events to the FDA.
If you or a loved one has had a problem with an implanted medical device, you should speak with your doctor, as well as possibly a medical malpractice attorney. When an implanted medical device malfunctions, that can have serious consequences for the patient, which could include another surgical procedure or an adverse medical event.
Call the Houston medical malpractice attorneys at Kennedy Hodges at 855-947-0707. We can help. Call us today to learn more or to schedule a free consultation. You can also visit our firm’s LinkedIn page.